US approves antigen test to diagnose COVID-19
May 10, 2020
Washington (US), May 10 (ANI: The US Food and Drug Administration (FDA) has authorized the use of antigen test for the first time to detect and treat COVID-19 infection.
"The U.S. Food and Drug Administration has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic," the FDA said in a statement issued on Saturday.
The new type of test manufactured by Quidel Corp. It was given emergency authorization by the U.S. Food and Drug Administration on Friday night, Sputnik reported.
"One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes," the agency added.
Quidel Corp. said that its test, called the Sofia 2 SARS Antigen FIA, can produce results within 15 minutes.
The FDA said that antigen tests are cheaper to produce, simpler to conduct and easier to implement at scale than the current testing apparatus. It is conducted by a nasal swab and immediately tested in the doctor's office or other point-of-care location, producing diagnostic results within minutes by quickly detecting proteins found on or within the virus.
At the same time, antigen tests are not as sensitive to the virus as molecular PCR tests.
"This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection. With this in mind, negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative," the FDA said.
According to Johns Hopkins University, the United States has over 1.3 million confirmed cases, with the death toll at 78,320.
